Standard: HHS - 21 CFR PART 310
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Definitions and interpretations.
As used in this part:
(a) The term act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201–902, 52 Stat. 1040 et seq., as amended; 21 U.S.C. 321–392).
(b) Department means the Department of Health and Human Services.
(c) Secretary means the Secretary of Health and Human Services.
(d) Commissioner means the Commissioner of Food and Drugs.
(e) The term person includes individuals, partnerships, corporations, and associations.
(f) The definitions and interpretations of terms contained in section 201 of the act shall be applicable to such terms when used in the regulations in this part.
(g) New drug substance means any substance that when used in the manufacture, processing, or packing of a drug, causes that drug to be a new drug, but does not include intermediates used in the synthesis of such substance
|Organization:||Food and Drug Administration (Medical Products Quality Assurance)|
|Document Number:||21 cfr part 310|
|Change Type:||COMPLETE REVISION|
|Most Recent Revision:||YES|
|Document #||Change Type||Update Date||Revision||Status|
|21 CFR PART 310||Change Type: COMPLETE REVISION||Update Date: 2017-04-01||Status: ACTV|
|21 CFR PART 310||Change Type: COMPLETE REVISION||Update Date: 2014-04-01||Status: ACTV|
|21 CFR PART 310||Change Type: COMPLETE REVISION||Update Date: 2015-04-01||Status: ACTV|
Standards That Reference This Standard
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